CALA: Innovator liability litigation could have stifled development of new drugs

CHARLESTON – The state Supreme Court’s ruling that a consumer can’t bring a claim against a brand-name drug manufacturer when they took a generic version is drawing reaction from both sides of the issue.

CHARLESTON – The state Supreme Court’s ruling that a consumer can’t bring a claim against a brand-name drug manufacturer when they took a generic version is drawing reaction from both sides of the issue.

The court, in a May 11 ruling, answered a certified question from the Fourth Circuit Court of Appeals and aligned with a majority of other courts that have ruled on the issue, which often is called innovator liability.

“Requiring the defendant in a products liability case to be either the manufacturer or the seller of the product is the majority rule in this country,” the 3-2 majority opinion stated. “Where the brand manufacturer neither manufactured nor sold the generic drug, it cannot impliedly represent that the generic drug is free of defects.”

The underlying case was McNair v. Johnson & Johnson et al. The McNairs claimed the wife developed acute respiratory distress after using the generic drug levofloxacin made by Dr. Reddy’s Laboratories Ltd. Levofloxacin originally was sold as Levaquin by Janssen, a subsidiary of Johnson & Johnson.

Rich Lindsay

Federal law requires labels for generic drugs to match those for the brand-name version.

Janssen was happy with the West Virginia ruling.

“We are pleased with the court’s decision to reject the innovator liability doctrine in West Virginia, which is consistent with rulings from courts across the country,” spokeswoman Sarah Freeman told The West Virginia Record. “For decades, it has been universally recognized that a consumer may only sue the manufacturer of the product that allegedly caused a plaintiff’s injury, not manufacturers who produce similar or name-brand products.

“This ruling will help us continue to focus on innovation, research, and developing new, life-saving medicines.”

An attorney for the McNairs disagreed.

“The McNairs, Ms. (Leslie) Brueckner (co-counsel) and myself are disappointed with the Court’s decision,” attorney Rich Lindsay of Tabor Lindsay & Associates in Charleston said. “All the court was asked to do was reaffirm West Virginia common law principles and recognize a common law right to remedy for hundreds of thousands of West Virginians.

“Instead, the court ruled by a 3-2 majority that West Virginia citizens – 80 percent of the prescription drug population – who are injured or killed by dangerously mislabeled generic drugs have no remedy. “

Lindsay said the ruling puts West Virginians at risk.

“By not allowing West Virginians, who like Ms. McNair have been seriously injured, a right to remedy against branded manufacturers that by federal mandate are in total and absolute control of the formula, content and labeling of subsequent sister generic prescription drugs, West Virginia citizens are at the mercy of the pharmaceutical industry,” he said. “It’s a terrible ruling. Or, to quote the dissent, it’s an ‘appalling’ decision that will directly and significantly harm West Virginia citizens.”

The executive director of a statewide legal reform group praised the ruling.

“We applaud the Supreme Court of Appeals of West Virginia for refusing to adopt ‘innovator liability,’ which attempts to hold makers of brand-name drugs liable for injuries allegedly caused by a generic version of a medication,” Roman Stauffer of West Virginia Citizens Against Lawsuit Abuse said. “If this type of litigation prevails, it could stifle the development of new drugs, which would have negative health consequences for society.

“In recent years, personal injury lawyers have been pushing these lawsuits across the country in hopes of hitting the lawsuit lottery. Thankfully, West Virginia joins nearly 40 other state and federal courts that have rejected innovator liability.”

The president of a statewide group for plaintiff’s attorney was critical of the ruling.

"Under current federal FDA regulations, generic drug manufacturers cannot initiate updates to prescription drug warning labels,” Stephen P. New of the West Virginia Association for Justice said. “They must print the labels used by the brand-name manufacturers verbatim.

“As a result, West Virginia patients and their doctors are at the mercy of those brand-name manufacturers and depend on them to provide adequate warnings. When they don't, West Virginia lives are at risk. The West Virginia Supreme Court's ruling is wrong.”

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